Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
The Radioimmunoassay for Morphine using iodine-125 with goat antibody and ammonium sulfate separation is a laboratory test system that measures morphine in patient specimens using an ammonium sulfate precipitation separation radioimmunoassay format with iodine-125 tracer and goat-derived antibodies. It is a Class 2 device requiring 510(k) premarket notification. The product code is DOE, regulated under 21 CFR 862.3640, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DOE
- Device Class
- FDA class 2
- Regulation Number
- 862.3640
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K010080 | INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST | May 29, 2001 | Substantially Equivalent | Alfa Scientific Designs, Inc. |
| K010079 | INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST | May 29, 2001 | Substantially Equivalent | Alfa Scientific Designs, Inc. |
| K011011 | LIVESURE MORPHINE SCREEN TEST | Apr 13, 2001 | Substantially Equivalent | Pan Probe Biotech, Inc. |
| K002418 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D | Nov 22, 2000 | Substantially Equivalent | Branan Medical Corporation |
| K951319 | ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION | Jun 01, 1995 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K935055 | ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) | Aug 09, 1994 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K933572 | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) | Apr 06, 1994 | Substantially Equivalent | Immunalysis Corporation |
| K881102 | MICROMEDIC MORPHINE RIA KIT | Jun 24, 1988 | Substantially Equivalent | Icn Micromedic Systems |
| K863913 | THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT | Mar 19, 1987 | Substantially Equivalent | Diagnostic Products Corp. |
| K864168 | MORPHINE ROCHE (R) EIA TEST | Mar 16, 1987 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE | Mar 24, 1983 | Substantially Equivalent | Hoffmann-La Roche, Inc. |
| K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE | Mar 24, 1983 | Substantially Equivalent | Hoffmann-La Roche, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.